Avedro Inc., a Boston-based ophthalmic medical device and pharmaceutical company, announces CE Mark clearance for its KXL II System. The KXL II System has the potential for non-surgical correction of myopia, as well as improving cataract surgery outcomes, with a procedure called PiXL™ (Photorefractive Intrastromal Cross-linking).
"As one of the first KXL II clinical sites, we experienced the amazing capabilities of customized accelerated cross-linking to achieve specific, reproducible and interim-stable refractive changes on the cornea," said A. John Kanellopoulos, MD, NYU Medical School and Member of Avedro's Medical Advisory Board. "It seems to me that every surgeon who has performed cross-linking has experienced refractive corneal changes. We now have a way to design and customize these refractive changes. If these initial clinical results continue to be repeated, as I believe they will, the potential seems unlimited."
David Muller, PhD, CEO of Avedro states, "The KXL II and PiXL procedure continue our mission to make refractive correction truly non-surgical. Treating myopia and other refractive disorders with PiXL has the potential to open up refractive correction to millions of people who have never considered Lasik surgery before, but would consider a non-surgical alternative."
Avedro products that have received CE Mark include: the KXL II System for performing PiXL, the KXL® System for performing Lasik Xtra® and Accelerated Cross-linking, and the Avedro family of proprietary single dose riboflavin formulations.